Benzinga | Jun 28, 2021 04:13PM EDT

Chiasma Reports Submission Of Marketing Authorization Application For MYCAPSSA To European Medicines Agency

Chiasma, Inc. (NASDAQ:CHMA), ("Chiasma" or the "Company"), a commercial-stage biopharmaceutical company utilizing its delivery platform technology to develop and commercialize oral therapies to improve the lives of patients with rare diseases currently treated with burdensome and painful injections, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval of MYCAPSSA(r) (oral octreotide capsules) as a maintenance therapy for adults with acromegaly.

The MAA is supported by positive results from Chiasma's global Phase 3 MPOWERED(tm) non-inferiority clinical trial comparing MYCAPSSA to long-acting injectable somatostatin analogs (iSSAs) for maintenance of biochemical response in patients with acromegaly who previously responded to both therapies. MYCAPSSA, the first and only oral somatostatin analog for the treatment of acromegaly approved by the Food and Drug Administration (FDA), is available in the U.S. for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with injectable octreotide or lanreotide.

"We are pleased to submit our marketing authorization application to the EMA as planned, as this marks an important step forward in our mission to expand the availability of MYCAPSSA to patients outside the U.S. suffering from acromegaly," said Raj Kannan, chief executive officer of Chiasma.